Abiraterone acetate, in combination with prednisone or prednisolone, is
currently indicated for the treatment of mCRPC (metastatic
castration-resistant prostate cancer) in adult men who are asymptomatic
or mildly symptomatic after failure of ADT in whom chemotherapy is not
yet clinically indicated, and in adult men whose disease has progressed
on or after a docetaxel-based chemotherapy regimen.1

“In combination with the significant benefits in survival and disease
progression, the new data from the LATITUDE clinical trial suggests that
abiraterone acetate plus prednisone, in combination with androgen
deprivation therapy, offers a much-needed efficacious treatment option
for patients with newly diagnosed metastatic disease,” said Dr Karim
Fizazi, Principal Investigator of the trial and Head of the Medical
Oncology Department at Institute Gustave Roussy, France. “These
results build upon previous LATITUDE findings published in the New
England Journal of Medicine in June and presented during ASCO
2017, which found a significant improvement in overall survival and
radiographic progression-free survival in patients with newly diagnosed
high-risk metastatic hormone-sensitive prostate cancer.”

In addition, an indirect comparison of abiraterone acetate plus
prednisone and docetaxel for the treatment of mHSPC was also presented
at ESMO. The systematic review, which examined results from LATITUDE as
well as several other studies, suggests that abiraterone acetate plus
prednisone, in combination with ADT, produces greater reductions in the
risk of progression and in risk of death vs ADT plus docetaxel for
patients with high risk or high volume disease.3

In addition to the benefits of abiraterone acetate plus prednisone seen
in early stage disease, additional findings presented at ESMO support
the use of abiraterone acetate plus prednisone in its current, mCRPC
indications. Preliminary results from the AQUARiUS observational study,
which prospectively collects PROs on quality of life, cognition, fatigue
and pain, suggest more favourable outcomes for perceived cognitive
impairments, functioning and fatigue for mCRPC patients treated with
abiraterone acetate plus prednisone compared to those treated with
enzalutamide, within the first three months after treatment initiation.4

“Janssen remains dedicated to addressing the challenges around
treatments and quality of life for both early and late stage prostate
cancer, including the thousands of patients with metastatic prostate
cancer in Europe that are diagnosed each year,” said Dr Ivo
Winiger-Candolfi, Oncology Solid Tumour Therapy Area Lead, Janssen
Europe, Middle East, Africa. “We are encouraged by the patient
reported outcomes from the AQUARiUS and LATITUDE trials, which further
support the use of abiraterone acetate plus prednisone in its current
indications, as well as the potential for use in an earlier stage of
prostate cancer, respectively. These new results suggest that
abiraterone acetate plus prednisone in combination with ADT has the
potential to become a standard of care for the treatment of newly
diagnosed, high-risk metastatic prostate cancer patients.”

-ENDS-

NOTES TO EDITORS

About high-risk metastatic hormone-sensitive
prostate cancer (mHSPC)

There are approximately 420,000 men diagnosed with prostate cancer in
Europe per year.5 Around 2%-43% (up to 180,000) have
metastatic prostate cancer.6,7,8 Not all prostate cancer is
the same. It ranges from cancer confined to the prostate gland to cancer
that has spread outside of the prostate to the lymph nodes, bones, or
other parts of the body. The extent or spread of prostate cancer
determines the stage.9 Hormone-sensitive prostate cancer
(HSPC) refers to a stage of the disease when the patient has not been
treated with ADT.10 Patients with newly diagnosed mHSPC,
particularly with high-risk characteristics, have a poor prognosis.10
ADT plus docetaxel has shown improved outcomes in mHSPC, but many
patients are not candidates for docetaxel and may benefit from
alternative therapy.11

About the LATITUDE Trial12

The Phase 3, multinational, multicentre, randomised, double-blind,
placebo-controlled LATITUDE study enrolled 1,199 newly diagnosed
patients with mHSPC (no prior treatment with ADT or =3 months treatment
with ADT before baseline) and was conducted at 235 sites in 34 countries
in Europe, Asia-Pacific, Latin America, and Canada. A total number of
597 patients were randomised to receive ADT in combination with
abiraterone acetate plus prednisone (n=597), while 602 patients were
randomised to receive ADT and placebos (n=602). Patients included had
high-risk mHSPC documented by positive bone scan or metastatic lesions
at the time of diagnosis on computed tomography (CT) or magnetic
resonance imaging (MRI). Additionally, patients had to have at least two
of the three following high-risk factors associated with poor prognosis:

Gleason score =8

=3 bone lesions

presence of measurable visceral metastases

These results served the basis for Janssen’s Type II variation
application submission to the European Medicines Agency (EMA), seeking
to expand the existing marketing authorisation for abiraterone acetate
plus prednisone or prednisolone to include the treatment of men with
newly-diagnosed, high-risk, metastatic hormone-sensitive prostate cancer
(mHSPC). If approved, this will broaden the use of abiraterone acetate
plus prednisone to include an earlier stage of prostate cancer than its
current indications.

Overall, the safety profile of ADT in combination with abiraterone
acetate plus prednisone was consistent with prior studies in patients
with metastatic castration-resistant prostate cancer (mCRPC). The most
common and anticipated adverse events were elevated incidences of
mineralocorticoid-related hypertension and hypokalaemia in the ADT in
combination with abiraterone acetate plus prednisone arm compared with
ADT and placebos. The incidence rate of grade 3 or higher hypertension
(20% vs. 10%) was greater than that observed in prior studies of
abiraterone acetate in mCRPC patients. There were no serious sequelae
from the increased rate of hypertension. The incidence of hypokalaemia
was higher than that reported in prior Phase 3 studies of abiraterone
acetate in mCRPC; however, only two patients discontinued treatment due
to hypokalaemia and there were no hypokalaemia-related deaths.

The observed degrees of hypertension and hypokalaemia were both
medically manageable with antihypertensive medications and potassium
supplements as needed, only rarely required treatment discontinuation,
and seldom led to serious consequences.

About the AQUARiUS Trial13

The prospective, multinational, observational AQUARiUS study
investigates the impact that both abiraterone acetate plus prednisone
and enzalutamide have on HRQoL, PROs, and medical resource use in
patients with mCRPC. The study enrolled 210 patients with mCRPC and has
been conducted at 27 sites in three countries in Europe. The estimated
study completion date is March 2018. Primary outcomes being measured are
HRQoL, fatigue, pain, cognitive function and medical resource use.

About abiraterone acetate

Abiraterone acetate plus prednisone / prednisolone is the only approved
therapy in mCRPC that inhibits production of androgens (which fuel
prostate cancer growth) at all three sources that are important in
prostate cancer - the testes, adrenals and the tumour itself.1,14,15

Abiraterone acetate plus prednisone / prednisolone has been approved in
more than 90 countries to date, and has been prescribed to approximately
330,000 men worldwide.16,17

Indications1

In 2011, abiraterone acetate in combination with prednisone /
prednisolone was approved by the European Commission (EC) for the
treatment of mCRPC in adult men whose disease has progressed on or after
a docetaxel-based chemotherapy regimen.

In December 2012, the EC granted an extension of the indication for
abiraterone acetate permitting its use, in combination with prednisone
or prednisolone, for the treatment of mCRPC, in adult men who are
asymptomatic or mildly symptomatic after failure of androgen deprivation
therapy in whom chemotherapy is not yet clinically indicated.1

Further Information1

The most common adverse reactions seen with abiraterone acetate plus
prednisone / prednisolone include urinary tract infection, hypokalaemia,
hypertension, and peripheral oedema.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at www.janssen.com/emea.
Follow us on http://www.twitter.com/janssenEMEA
for our latest news.

Cilag GmbH International; Janssen Biotech, Inc.; and Janssen-Cilag
International NV are part of the Janssen Pharmaceutical Companies of
Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding the
continued development and potential of abiraterone acetate plus
prednisone. The reader is cautioned not to rely on these forward-looking
statements. These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or known or unknown
risks or uncertainties materialise, actual results could vary materially
from the expectations and projections of Janssen-Cilag International NV,
any of the other Janssen Pharmaceutical Companies and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in behaviour
and spending patterns or financial distress of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care cost
containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson & Johnson's
Annual Report on Form 10-K for the fiscal year ended January 1, 2017,
including under “Item 1A. Risk Factors,” its most recent Quarterly
Report on Form 10-Q, including in the section captioned “Cautionary Note
Regarding Forward-Looking Statements,” and the company's subsequent
filings with the Securities and Exchange Commission. Copies of these
filings are available online at www.sec.gov,
www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.

13 Clinicaltrials.gov. A Study to Investigate the Impact of
Abiraterone Acetate and Enzalutamide on Health-related Quality of Life,
Participant-Reported Outcomes, and Medical Resource Use in Metastatic
Castration-resistant Prostate Cancer Participants (AQUARiUS). Available
at: https://clinicaltrials.gov/ct2/show/study/NCT02813408.
Last accessed September 2017.